An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

February 22, 2024 updated by: RAPT Therapeutics, Inc.

A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis

Phase 2 study of RPT193 in adults with atopic dermatitis

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M7G1
        • SimcoDerm Medical and Surgical Dermatology Center
      • Hamilton, Ontario, Canada, L8L 3C3
        • Leader Research
      • Ottawa, Ontario, Canada, K1H 1E4
        • Red Maple Trials Inc.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Perseverance Research Center
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Research Trials, LLC
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Los Angeles, California, United States, 90036
        • Grimes Center
      • Los Angeles, California, United States, 90056
        • Wallace Medical Group
      • North Hollywood, California, United States, 91606
        • Velocity Clinical Research
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Thousand Oaks, California, United States, 91320
        • Clinical Trials Research Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Foxhall Research Center
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education, LLC
      • Coral Gables, Florida, United States, 33134
        • Driven Research LLC
      • Delray Beach, Florida, United States, 33484
        • Palm Beach Dermatology Group
      • Margate, Florida, United States, 33063
        • Gsi Clinical Research
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group, LLC
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Georgia
      • Macon, Georgia, United States, 31217
        • Skin Care Physicians of Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Dermatology Clinical Research, Inc.
      • Savannah, Georgia, United States, 31419
        • Georgia Skin & Cancer Clinic
    • Illinois
      • Darien, Illinois, United States, 60561
        • University Dermatology and Vein Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • Indianapolis, Indiana, United States, 46202
        • Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center PC
    • Kentucky
      • Louisville, Kentucky, United States, 40217'
        • Skin Sciences Pllc
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • DelRicht Research
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Schweiger Dermatology Group, PC Research Division
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • MetroBoston Clinical Partners
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Fivenson Dermatology
      • Saint Joseph, Michigan, United States, 49085
        • St. Joseph Dermatology and Vein Clinic
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Advanced Dermatology of the Midlands
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists PC (Schlessinger MD)
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • Schweiger Dermatology Group
    • New York
      • Kew Gardens, New York, United States, 11415
        • Forest Hills Dermatology Group
      • New York, New York, United States, 10022
        • Juva Skin & Laser Center
      • New York, New York, United States, 10029
        • Ichan School of Medicine at Mount Sinai
      • New York, New York, United States, 10128
        • Markowitz Medical, PLLC
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Optima Research - Boardman
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center Inc.
      • Austin, Texas, United States, 78759
        • DermResearch
      • Cypress, Texas, United States, 77433
        • Studies in Dermatology, LLC
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment and Research Center
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
      • Sugar Land, Texas, United States, 77479
        • Complete Dermatology
      • Sugar Land, Texas, United States, 77479
        • Acclaim Dermatology
    • Utah
      • South Jordan, Utah, United States, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Richmond, Virginia, United States, 23233
        • West End Dermatology Associates
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
  • 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening
  • inadequate response to a ≥1 month treatment with topical medications
  • Atopic dermatitis covering ≥10% of the body surface area
  • EASI score ≥16
  • Validated Investigator Global Assessment (VIGA) ≥3
  • Use of emollient(s) at least 2x daily for 1 week prior to baseline
  • Negative coronavirus disease (COVID)-19 results at screening

Exclusion Criteria:

  • Uncontrolled moderate-to-severe asthma
  • Uncontrolled diabetes
  • Stage III or IV cardiac failure
  • Severe renal condition
  • Major surgery within 8 weeks of screening
  • Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline
  • Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline
  • Received live or live-attenuated vaccine within 4 weeks of baseline
  • Prior receipt of RPT193

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RPT193 400 mg
RPT193 400 mg oral tablet administered daily for 16 weeks
Drug: RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Experimental: RPT193 200 mg
RPT193 200 mg oral tablet administered daily for 16 weeks
Drug: RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Experimental: RPT193 50 mg
RPT193 50 mg oral tablet administered daily for 16 weeks
Drug: RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Placebo Comparator: Placebo
Matching placebo oral tablet administered daily for 16 weeks
Other: Placebo
Nonactive placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy
Time Frame: 16 weeks
% change in Eczema Area Severity Index (EASI)
16 weeks
Safety as measured by adverse events
Time Frame: 16 weeks
Incidence of treatment-emergent adverse events
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAPT Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPT193-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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